This non-randomized, open label, multi-site, first-in-human, Phase 1/2 study CRC-403 will evaluate the safety and efficacy of bbT369 in subjects with relapsed and/or refractory B cell non-Hodgkin's lymphoma (NHL). A long-term follow-up (LTF-01 \[NCT06798298\]) is planned, in which subjects who received bbT369 will be followed for up to 15 years after drug product infusion to evaluate for safety and continued efficacy.
Former Sponsor 2seventy bio The trial was intended to be a Phase 1/2 trial, but no participants were enrolled in Phase 2, consequently the study was terminated in Phase 1.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
bbT369 is a genetically modified autologous T cell immunotherapy product consisting of T cells that are transduced with a single lentiviral vector (LVV) to express anti-CD79a and anti-CD20 chimeric antigen receptors (CARs) and transfected with an mRNA encoding the CBLB-targeting megaTAL enzyme to edit the CBLB gene, suspended in a cryopreservative solution.
Stanford Cancer Institute
Stanford, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Moffitt Cancer Center
Tampa, Florida, United States
Sarah Cannon
Nashville, Tennessee, United States
Phase 1: Incidence of safety events including: adverse events (AEs), adverse events of special interest (AESIs), and dose limiting toxicities (DLTs)
Time frame: Day 1 through Month 24
Phase 1: Rates of disease-specific response criteria including complete response rate(CRR), partial response rate(PRR), stable disease rate(SDR), and progressive disease rate(PDR) according to the Lugano 2014 response criteria as assessed by Investigator
Time frame: Day 1 through Month 24
Phase 1: Overall Response Rate (ORR) according to the Lugano 2014 response criteria as assessed by Investigator
Time frame: Day 1 through Month 24
Phase 1: Time to response (TTR)
Time frame: Day 1 through Month 24
Phase 1: Time to complete response (TCR)
Time frame: Day 1 through Month 24
Phase 1: Time to next treatment for B Cell NHL (TTNT)
Time frame: Day 1 through Month 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.